Clinical Trial: Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Hodgkin's Lymphoma

This study is currently recruiting patients.

Sponsors and Collaborators: German Hodgkin's Lymphoma Study Group
European Organization for Research and Treatment of Cancer
EBMT Solid Tumors Working Party
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplantation is more effective in treating relapsed Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens followed by peripheral stem cell transplantation in treating patients who have relapsed Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent adult Hodgkin's lymphoma
 Drug: carmustine
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dexamethasone
 Drug: etoposide
 Drug: filgrastim
 Drug: melphalan
 Drug: methotrexate
 Drug: vincristine
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics:  Hodgkin's Disease

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Induction Chemotherapy Followed By Combination Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation With or Without High-Dose Sequential Chemotherapy in Patients With Relapsed Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse [remission duration 3-12 months] vs late first relapse [remission duration more than 12 months] vs second relapse without prior high-dose chemotherapy salvage [remission duration after salvage at least 3 months]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change).

All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms.

Patients are followed at 100 days after PBSC transplantation, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 220 patients (110 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma
  • Early or late first relapse
  • Complete or partial remission for at least 3 months after completion of prior COPP/ABVD, COPP/ABV/IMEP, MOPP/ABV, ABVD, BEACOPP, or other polychemotherapy regimen with or without radiotherapy
  • No prior salvage therapy OR
  • Second relapse
  • Any prior salvage therapy
  • No prior high-dose chemotherapy

PATIENT CHARACTERISTICS: Age:

  • 18 to 60

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-2

Life expectancy:

  • More than 3 months with treatment

Hematopoietic:

  • Absolute neutrophil count at least 2,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg)
  • No unstable angina
  • No New York Heart Association class III or IV heart disease (congestive heart failure)
  • No myocardial infarction within the past 6 months
  • No uncontrolled atrial or ventricular cardiac arrhythmias

Pulmonary:

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No poorly controlled diabetes
  • No cerebral disorder
  • No other concurrent malignancy except adequately treated basal cell skin cancer or cervical intraepithelial neoplasia
  • No significant non-malignant disease
  • No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Other:

  • At least 6 months since prior coronary angioplasty
  • No other concurrent investigational drugs
  • No concurrent non-steroidal anti-inflammatory drugs, salicylate, sulfonamide, trimethoprim, allopurinol, aminoglycoside, amoxicillin, or probenecid during high-dose methotrexate administration

Location and Contact Information


Belgium
      Algemeen Ziekenhuis Sint Lucas, Gent,  B-9000,  Belgium; Recruiting
Contact Person  32-9-224-6111 

      Institut Jules Bordet, Brussels,  1000,  Belgium; Recruiting
Contact Person  32-2-541-3111 

      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium; Recruiting
Contact Person  32-3-821-3000 

      Ziekenhuis Network Antwerpen Middelheim, Antwerp,  2020,  Belgium; Recruiting
Contact Person  32-3-280-3111 

Croatia
      University Hospital Rebro, Zagreb,  10000,  Croatia; Recruiting
Contact Person  385-1-233-3368 

Denmark
      Rigshospitalet, Copenhagen,  2100,  Denmark; Recruiting
Contact Person  45-3545-3545 

Germany
      Carl - Thiem - Klinkum Cottbus, Cottbus,  D-03048,  Germany; Recruiting
Christian Rudolph, MD  49-355-46-2023    c.rudolph@ctk.de 

      Charite - Campus Charite Mitte, Berlin,  D-10117,  Germany; Recruiting
Contact Person  49-30-450-513-002 

      Charite - Campus Virchow Klinikum, Berlin,  D-13353,  Germany; Recruiting
B Doerken, MD  49-30-450-553-111 

      Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin,  D-12200,  Germany; Recruiting
Eckhard Thiel, MD  49-30-8445-2337    haema.cbf@charite.de 

      Clinic for Bone Marrow Transplantation and Hematology and Oncology, Idar-Oberstein,  D-55743,  Germany; Recruiting
Axel Arthur Fauser, MD, PhD  49-6781-66-1580 

      Diakonissen-Krankenhaus Stuttgart, Stuttgart,  D-70176,  Germany; Recruiting
Else G. Heidemann, MD  49-711-991-3501 

      Dr. Horst-Schmidt-Kliniken, Wiesbaden,  D-65199,  Germany; Recruiting
Norbert Frickhofen, MD  49-611-43-3009    norbert.frickhofen@hsk-wiesbaden.de 

      Evangelische Krankenhaus Hamm, Hamm,  DOH-59063,  Germany; Recruiting
Leopold Balleisen, MD  49-2381-589-1333    LBalleisen@evkhamm.de 

      Evangelisches Krankenhaus Essen Werden, ESSEN,  D-45239,  Germany; Recruiting
Heil, MD  49-0201-4089-2099 

      Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald,  D-17487,  Germany; Recruiting
Gottfried Doelken, MD  49-3834-866-700 

      Klinikum der Friedrich-Schiller Universitaet Jena, Jena,  D-07740,  Germany; Recruiting
Hoeffken, MD  49-9641-932-4200 

      Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen, Munich,  D-81377,  Germany; Recruiting
Wolfgang Hiddemann, MD, PhD  49-89-7095-2551 

      Klinikum Oldenburg, Oldenburg,  D-26133,  Germany; Recruiting
Hans J. Illiger, MD  49-441-403-2611    illiger.h.j@klinikum-oldenburg.de 

      Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich,  D-81675,  Germany; Recruiting
Christian Peschel, MD  49-89-4140-4111    christian.peschel@lrz.tu-muenchen.de 

      Krankenhaus Maria Hilf GmbH, Moenchengladbach,  DOH-41063,  Germany; Recruiting
H. E. Reis, MD  49-2161-892-2200 

      Krankenhaus Muenchen Schwabing, Munich,  80804,  Germany; Recruiting
Christoph Nerl, MD, PhD  89-3068-2228 

      Krankenhaus Siloah - Medizinische Klinik II, Hannover,  D-30449,  Germany; Recruiting
Hartmut Kirchner, MD  49 511 9272801    siloahcc@hannover.sgh-net.de 

      Martin Luther Universitaet, Halle,  D-06120,  Germany; Recruiting
Hans-Joachim Schmoll, MD, PhD  49-345-557-2924    hans-joachim.schmoll@medizin.uni-halle.de 

      Medizinische Hochschule Hannover, Hannover,  D-30625,  Germany; Recruiting
Arnold Ganser, PhD, MD  49-511-532-3020    ganser.arnold@mh-hannover.de 

      Medizinische Poliklinik, Bonn,  D-53111,  Germany; Recruiting
Ko, MD  49-228-287-2263 

      Medizinische Universitaetsklinik I, Cologne,  D-50924,  Germany; Recruiting
Volker Diehl, MD  49-221-478-7408    v.diehl@uni-koeln.de 

      Medizinische Universitaetsklinik und Poliklinik, Heidelberg,  69115,  Germany; Recruiting
Anthony D. Ho, MD, PhD  49-6221-56-8001    anthony_ho@med.uni-heidelberg.de 

      Saint Georg-Hospital, Hamburg,  D-20099,  Germany; Recruiting
Norbert Schmitz, MD, PhD  49-40-2890-2005    Norbert.Schmitz@ak-stgeorg.lbk.hh.de 

      St. Bernward Krankenhaus 1267, Hildeshem,  D-31134,  Germany; Recruiting
Urbanitz, MD  49-5-12-19-00 

      Staedt Klinikum Karlsruhe GGMBH, Karlsruhe,  76133,  Germany; Recruiting
Joerg Th Fischer, MD  49-721-974-3001    haematologie@klinikum-karlsruhe.de 

      Staedtisches Klinikum Dessau, Dessau,  D-06822,  Germany; Recruiting
Axel Florschuetz, MD  49-340-501-1214 

      Universitaetsklinikum Essen, ESSEN,  D-45122,  Germany; Recruiting
Ulrich Duehrsen  49-201-723-2417 

      Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Luebeck,  D-23538,  Germany; Recruiting
Thomas Wagner, MD  49-451-500-2670    thomas.wagner@ukl.uni-luebeck.de 

      Universitaets-Krankenhaus Eppendorf, Hamburg,  D-20246,  Germany; Recruiting
D.K. Hossfeld, MD  49-40-428-032-960    dk.hossfeld@uke.uni-hamburg.de 

      Universitatsklinik - Saarland, Homburg,  D-66421,  Germany; Recruiting
Michael G.M. Pfreundschuh, MD  49-6841-162-3084 

      Urologische Klinik, Giessen,  D-35392,  Germany; Recruiting
Hans Pralle, MD, PhD  49-641-994-2650    hans.pralle@innere.med.uni-giessen.de 

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
Contact Person  31-20-566-9111 

      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands; Recruiting
Contact Person  31-43-387-6543 

      Leiden University Medical Center, Leiden,  2300 RC,  Netherlands; Recruiting
Contact Person  31-71-526-911 

      Maxima Medisch Centrum - locatie Veldhoven, VELDHOVEN,  5500 MB,  Netherlands; Recruiting
Contact Person  31-40-888-8000 

      Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam,  1066 CX,  Netherlands; Recruiting
Contact Person  31-20-512-9111 

      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands; Recruiting
Contact Person  31-20-599-9111 

      University Medical Center Groningen, Groningen,  9700 RB,  Netherlands; Recruiting
Contact Person  31-50-361-6161 

      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands; Recruiting
Contact Person  31-80-361-1111 

Poland
      Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw,  02-781,  Poland; Recruiting
Contact Person  48-22-546-2169 

Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  P-3001-301,  Portugal; Recruiting
Contact Person  351-39-403-939 

Switzerland
      UniversitaetsSpital, Zurich,  CH-8091,  Switzerland; Recruiting
Alexander Knuth, MD  41-1-255-9778 

Study chairs or principal investigators

Andreas Engert, MD,  Medizinische Universitaetsklinik I   
J. W. Baars, MD, PhD,  Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital   
Norbert Schmitz, MD, PhD,  Saint Georg-Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068981; GHSG-HD-R2; EBMT-GHSG-HD-R2; EORTC-20011; NCT00025636
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025636
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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